Cognitive Behavioral Therapy for Irritable Bowel Syndrome

(U54_P3_CBT Trial)

Overseen By Regan Cortessis

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Narcotics, Opioids, Systemic steroids, others

Disqualifiers: Obesity, Major psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8-10 weeks

92 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that alter GI motility and gastric pH at least 72 hours before any physiologic test visit and during the baseline and treatment intervention. You will need approval from your primary care provider to stop these medications. Rescue medications like bisacodyl and loperamide are allowed during intervention periods but not during baseline or within 3 days of follow-up MRI.

What data supports the effectiveness of this treatment for irritable bowel syndrome?

Research shows that cognitive therapy, a part of cognitive behavioral therapy, significantly reduces symptoms of irritable bowel syndrome and improves psychological well-being, with benefits lasting at least three months after treatment. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for humans?

Mindfulness-based interventions, which include forms of Cognitive Behavioral Therapy, are generally considered safe, portable, and cost-effective for managing conditions like depression and PTSD. They can be recommended as an additional strategy alongside standard care. ^{6 7 8 9 10}

How is Cognitive Behavioral Therapy different from other treatments for irritable bowel syndrome?

Cognitive Behavioral Therapy (CBT) is unique for irritable bowel syndrome (IBS) because it focuses on changing thought patterns and behaviors that contribute to symptoms, rather than relying on medication or dietary changes. It addresses the psychological aspects of IBS, such as stress and anxiety, which can worsen symptoms, and has been shown to be effective in improving both mental health and IBS symptoms. ^{11 12 13 14 15}

What is the purpose of this trial?

Cognitive Behavioral Therapy (CBT) is the most well researched and most effective treatment for IBS targeting the brain-gut-microbiome (BGM) axis, and preliminary data show that this therapeutic effect is associated with a reduction of brainstem connectivity with other brain networks. The increased prevalence of IBS in women, the higher rate of comorbid non-GI pain conditions, as well as the higher prevalence in female IBS of increased sensitivity to a variety of internal and external stimuli (multisensory sensitivity) suggest the presence of important sex differences in some of these BGM mechanisms. Research performed by UCLA SCOR during previous funding has established an increased responsiveness of the CRF-Locus Coeruleus (LCC) system in female IBS subjects, suggesting that this central noradrenergic brainstem system plays an important role in IBS pathophysiology. In addition, the study team's earlier research has begun to identify clinical, functional and structural brain mechanisms that may underlie these sex effects. Based on the preliminary data, the overall goal of this project is to use CBT as a probe to study the relationship between specific disease-related alterations of the brain, the gut microbiome, and symptomatic outcome, and identify the role of sex differences in these relationships. Investigators will study male and female IBS patients before and after CBT using the advanced neuroimaging and microbiome technologies of the overall SCOR.

Eligibility Criteria

This trial is for men and women aged 18-55 with IBS, meeting ROME IV criteria. Women must be premenopausal, not pregnant or breastfeeding, and willing to use non-hormonal birth control. Participants should have no major psychiatric diagnoses or significant medical conditions that could interfere with the study.

Inclusion Criteria

I am not pregnant or breastfeeding and haven't been for at least 6 months.

I will use non-hormonal birth control or avoid pregnancy during the study.

I use hormonal birth control and still have a monthly period.

Exclusion Criteria

I haven't taken antibiotics or probiotics within 3 months before joining the study.

I haven't had cancer, except for treated skin cancer, in the last 5 years.

My average abdominal pain is 3 or more on a scale of 0 to 10.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-3 weeks

1 visit (in-person), 1 visit (virtual)

MRI and Baseline Assessment

Participants undergo MRI scanning and complete baseline assessments

1-3 weeks

1 visit (in-person)

Treatment

Participants receive 8-10 weeks of remote cognitive behavioral therapy

8-10 weeks

Weekly online sessions

Post-Treatment MRI

Participants return for a post-CBT MRI visit identical to the baseline assessment

2-3 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cognitive Behavioral Therapy

Trial Overview The effectiveness of Cognitive Behavioral Therapy (CBT) on IBS is being tested, focusing on sex differences in response. The study involves advanced neuroimaging and microbiome analysis before and after CBT to understand brain-gut-microbiome interactions.

Participant Groups

Group I: Cognitive Behavioral Treatment Arm Experimental Treatment 1 Intervention

Subjects in the "Cognitive Behavioral Treatment" Arm will undergo 8-10 weeks of remote cognitive behavioral therapy. Subjects will complete modules on their phones and will be monitored by study coordinators for support and treatment completion.

Group II: Usual Care Arm Active Control 1 Intervention

Subjects in the "Usual Care" Arm will undergo 8-10 weeks of continued lifestyle. Subjects will be asked to report any new medications or lifestyle changes to study coordinators throughout the 8-10 weeks.

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

In a study of 34 patients with irritable bowel syndrome, individualized cognitive treatment (CT) led to significantly greater reductions in gastrointestinal symptoms compared to self-help support groups and a waiting-list control over an 8-week period.

CT also resulted in notable improvements in psychological measures of depression and anxiety, with these benefits maintained and even enhanced at a 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled comparison of cognitive therapy and self-help support groups in the treatment of irritable bowel syndrome. Payne, A., Blanchard, EB.[2022]

The study presents a behavior analysis and treatment plan for a patient with chronic irritable bowel syndrome (IBS), highlighting the potential benefits of this approach for patients who have not responded well to traditional treatments.

The findings suggest that behavior analysis may offer a valuable alternative for managing IBS in patients with poor treatment prognosis, although specific outcomes and methods are not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy for irritable bowel syndrome. A case report. Garrick, TR.[2019]

Cognitive behavior therapy (CBT) was effective in reducing anxiety and improving symptoms in a chronic case of Irritable Bowel Syndrome (IBS), highlighting its potential as a psychological intervention.

The study suggests that psychological interventions like CBT can enhance the quality of life and psychosocial functioning for individuals suffering from IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritable bowel syndrome and its psychological management. Tripathi, R., Mehrotra, S.[2020]

In a study of 20 patients with irritable bowel syndrome (IBS), those who received intensive cognitive therapy showed significantly greater reductions in gastrointestinal symptoms compared to those who only monitored their symptoms, with a p-value of .005.

At the end of the treatment, 80% of the cognitive therapy group experienced clinically significant improvement, while only 10% of the symptom monitoring group did, and these benefits were maintained at a 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy for irritable bowel syndrome. Greene, B., Blanchard, EB.[2019]

A psycho-educational intervention for 69 IBS patients led to significant improvements in gastrointestinal symptom severity, visceral sensitivity, depression, and quality of life, with benefits maintained at a 3-month follow-up.

The intervention was particularly effective for patients with low to moderate baseline quality of life, indicating that it can help change negative thoughts and fears about IBS symptoms, leading to meaningful symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: symptoms of the irritable bowel syndrome are improved by a psycho-education group intervention. Labus, J., Gupta, A., Gill, HK., et al.[2022]

In a systematic review of 19 randomized controlled trials involving 2188 participants, 10% of those undergoing cognitive behavior therapy (CBT) for health anxiety reported adverse events, and 17% dropped out of the treatment, indicating that while CBT is effective, it can have unwanted outcomes.

In a secondary study of 336 participants, 17% reported adverse events, and 0-10% experienced overall symptom deterioration, suggesting that while CBT is generally effective, there is variability in individual experiences and a need for strategies to minimize dropouts and adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unwanted outcomes in cognitive behavior therapy for pathological health anxiety: a systematic review and a secondary original study of two randomized controlled trials. Axelsson, E., Hedman-Lagerlöf, E.[2023]

Mindfulness-based cognitive therapy (MBCT) adapted for combat PTSD showed significant improvement in PTSD symptoms compared to treatment-as-usual, with a notable reduction in avoidance symptoms and PTSD-related negative cognitions.

The study involved 37 participants (20 in the MBCT group and 17 in the TAU group) over an 8-week period, and 75% of MBCT completers demonstrated good compliance and clinically meaningful improvements in their PTSD assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). King, AP., Erickson, TM., Giardino, ND., et al.[2022]

An 8-week mindfulness-based cognitive therapy (MBCT) program is being tested for its effectiveness in improving mindfulness skills and reducing self-harm behaviors in patients with borderline personality disorder (BPD) who engage in non-suicidal self-injury (NSSI).

The study will involve 60 BPD patients and aims to demonstrate that MBCT is more effective than waiting list or supportive therapy in enhancing emotion and impulse control, which are critical for managing BPD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Borderline personality disorder and non-suicidal self-injury: the role of mindfulness training in risk reduction]. Kresznerits, S., Zinner-Gérecz, Á., Perczel-Forintos, D.[2023]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

Mindfulness-based cognitive therapy (MBCT) is effective for preventing relapse in recurrent depression, showing efficacy comparable to maintenance antidepressants, based on several randomized controlled trials.

Preliminary studies suggest that MBCT may also be beneficial for treating active depression, including treatment-resistant cases, as well as in bipolar disorder and anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: theory and practice. Sipe, WE., Eisendrath, SJ.[2018]

Cognitive Behavioral Therapy (CBT) has been shown to be an effective treatment for patients with refractory Irritable Bowel Syndrome (IBS), supported by multiple site trials in the UK and USA.

Despite its efficacy, CBT is often only available in specialized care settings, highlighting the need for improved access and delivery methods, such as digital therapeutics, to maximize its benefits for IBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills over pills? A clinical gastroenterologist's primer in cognitive behavioral therapy for irritable bowel syndrome. Lackner, JM.[2022]

Irritable bowel syndrome (IBS) symptoms are often linked to underlying emotional disorders like depression and anxiety, suggesting that a biopsychosocial approach is essential for effective treatment.

Psychotherapy and antidepressants are key components in managing IBS, with a focus on addressing emotional and psychosocial factors to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritable bowel syndrome. Toward a biopsychosocial systems understanding. Crouch, MA.[2005]

Psychological treatments, such as cognitive behavior therapy and hypnotherapy, have been shown to significantly improve symptoms of irritable bowel syndrome (IBS) and enhance mental health outcomes, as evidenced by a review of nearly 60 studies.

The review highlights the importance of addressing the psychological aspects of IBS, including anxiety and depression, and suggests that future research should explore the effectiveness of mind-body therapies like mindfulness-based stress reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Irritable bowel syndrome: comorbid psychiatric disorders and psychological treatment options]. Gajdos, P., Rigó, A.[2019]

Telephone-based CBT (TCBT) and web-based CBT (WCBT) for refractory irritable bowel syndrome (IBS) were well-received by participants, who appreciated the flexibility and support from therapists, leading to lasting positive impacts on their understanding of IBS and improvements in symptoms and quality of life.

Despite some initial skepticism and challenges in maintaining motivation, participants reported significant benefits from both forms of CBT, suggesting these methods could enhance access to effective treatment for IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Telephone-Based and Web-Based Cognitive Behavioral Therapy for Irritable Bowel Syndrome: Longitudinal Qualitative Study. Hughes, S., Sibelli, A., Everitt, HA., et al.[2021]

There is currently no single therapy that effectively treats all symptoms of Irritable Bowel Syndrome (IBS), highlighting the complexity of the condition.

A combination of various treatments, including medication, lifestyle changes, and psychotherapies, is often necessary to provide symptom relief tailored to individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The general aspects of the treatment of irritable bowel syndrome]. Iwai, A., Miyahara, T., Koyama, H., et al.[2011]

References

1. United States pubmed.ncbi.nlm.nih.gov

A controlled comparison of cognitive therapy and self-help support groups in the treatment of irritable bowel syndrome. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Behavior therapy for irritable bowel syndrome. A case report. [2019]

3. India pubmed.ncbi.nlm.nih.gov

Irritable bowel syndrome and its psychological management. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive therapy for irritable bowel syndrome. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: symptoms of the irritable bowel syndrome are improved by a psycho-education group intervention. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Unwanted outcomes in cognitive behavior therapy for pathological health anxiety: a systematic review and a secondary original study of two randomized controlled trials. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). [2022]

8. Hungary pubmed.ncbi.nlm.nih.gov

[Borderline personality disorder and non-suicidal self-injury: the role of mindfulness training in risk reduction]. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: theory and practice. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Skills over pills? A clinical gastroenterologist's primer in cognitive behavioral therapy for irritable bowel syndrome. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Irritable bowel syndrome. Toward a biopsychosocial systems understanding. [2005]

13. Hungary pubmed.ncbi.nlm.nih.gov

[Irritable bowel syndrome: comorbid psychiatric disorders and psychological treatment options]. [2019]

14. Canada pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Telephone-Based and Web-Based Cognitive Behavioral Therapy for Irritable Bowel Syndrome: Longitudinal Qualitative Study. [2021]

15. Japan pubmed.ncbi.nlm.nih.gov

[The general aspects of the treatment of irritable bowel syndrome]. [2011]